MAXIMUM STRENGTH COLD SORE TREATMENT- maximum strength cold sore treatment gel 
Retail Business Services, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Maximum Strength Cold Sore Treatment – Drug Facts

Active ingredients

Camphor 3.00%

Menthol 1.00%

Phenol 1.50%

White Petrolatum 89.20%

Purpose

Cold sore/fever blister treatment

Skin Protectant

Uses

•
For treatment of cold sores/fever blisters on the face or lips
•
Temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters
•
Temporarily protects minor cuts, scrapes, burns, and sores
•
Helps prevent and temporarily protects chapped or cracked skin and lips

Warnings

For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician.

Allergy alert: Do not use if you are allergic to any of the ingredients in this product.

When using this product

avoid contact with eyes. Use only as directed.

Stop use and consult a doctor if

the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

•
Clean the affected area
•
Apply a small amount of this product to the affected area 1 to 3 times daily
•
Rub in gently
•
May be covered with a sterile bandage
•
Wash hands before and after applying cream
•
Do not share this product with anyone

Children under 12 years of age: ask a doctor

Other information

store at room temperature

Inactive ingredients

Eucaluptol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thymol, Tocopheryl Nicotinate

Questions or comments?

Call us toll-free at 1-877-242-3234 Monday-Friday, 9 a.m. to 5 p.m. EST.

Serious side effects associated with use of this product may be reported to this number.

Principal Display Panel

CAREone®

Maximum Strength

Camphor 3.00%, Menthol 1.00%, Phenol 1.50%, White Petrolatum 89.20%

COLD SORE TREATMENT

Cold Sore/Fever Blister Treatment & Skin Protectant

New & Improved

TEMPORARY RELIEF OF PAIN & DISCOMFORT

Paraben Free

With Tea Tree Oil

Medicated

Phthalate Free

Sulfate Free

Works on Contact

Applied Clear

OUR PHARMACIST RECOMMENDED

NET WT 0.07 oz (2.0 g)

PDP
MAXIMUM STRENGTH COLD SORE TREATMENT 
maximum strength cold sore treatment gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-412
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM892 mg  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)30 mg  in 1 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL15 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)  
THYMOL (UNII: 3J50XA376E)  
EUCALYPTOL (UNII: RV6J6604TK)  
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72476-412-012 g in 1 TUBE; Type 0: Not a Combination Product02/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/01/2020
Labeler - Retail Business Services, LLC (967989935)

Revised: 12/2021
Document Id: 632d77de-9792-40f9-a523-815088ee987f
Set id: 9c476b0b-3534-2693-e053-2a95a90a26de
Version: 2
Effective Time: 20211209
 
Retail Business Services, LLC